It is beneficial to control bleeding during surgery in order to maintain adequate vision during the procedure and to avoid the serious complications incurred by blood loss. Although there are many ways to control bleeding in soft tissue, methods to acheive hemostasis in bony tissues have been limited. Furthermore, existing methods employing conventional bone wax can interfere with subsequent healing of the bony tissues.
One of the earliest solutions of hemostasis in bone was developed by Horsley and Squire. Horsley published the composition of his "antiseptic wax" as: seven parts beeswax, one part almond oil, and 1% salicylic, sterilized by boiling (Horsley, V. (1892), Brit Med J., 1: 1165). First report of this agent's clinical use to control bleeding from bone was made by Parker (Parker, R. (1892), Brit Med J, 1: 1076-7). Despite the great surgical advances of the century, current bone wax is remarkably similar to Horsley's composition: 88% refined beeswax and 12% isopropylpalmitate. (Baldauf, R. and I. Kanat (1986), J Foot Surg., 25: 456-458). Conventional bone wax has no inherent hemostatic quality; its effect is via tamponade of marrow spaces. The material is not resorbed by the adjacent bone or local surrounding tissues. Therefore, it can induce inflammatory response and inhibit bone regeneration. Furthermore, bone wax may lower the bacterial clearance in cancellous bone (Johnson, P. and Fromm, D. (1981), Surgery, 89(2): 206-9), or result in wax embolization (Robicsek, F. et al. (1981), Ann Thorac Surg., 31(4): 357-9).
Although there have been some advances in the area of hemostatic agents for skeletal tissue, conventional bone wax continues to be the most commonly used hemostatic agent. Thus, the need exists for a composition that can easily be delivered to an osteotomy gap and that controls hemostasis of bone without delaying or inhibiting bone repair. There exists a need for an effective resorbable bone agent that has inherent hemostatic qualities, is easily delivered to the site, is compatible with osseous repair and is biodegradable.